Editors' Picks of Pharmaceutical Science & Technology Innovations
FDA's recent guidance on process validation emphasizes scientific understanding and the effective control of manufacturing
processes. The document reflects the shift towards monitoring and measuring process parameters to ensure product quality.
This month's products can help drugmakers continue to verify that their production lines are operating as expected. A new
mixer from Silverson provides users with information about the mixing process. Software from TrackWise helps companies track
documents related to corrective actions. A process-control suite from Honeywell is designed to enable central control of all
systems at a manufacturing plant.
Software centrally monitors process-control systems
Sparta Systems's TrackWise Preclinical GLP and Clinical GCP Auditing Solutions includes a wide range of document-control functions
that enable the transfer of attachments, through a web service, to other enterprise applications. The software is designed
to manage all information securely in a centralized, scalable, and reliable enterprise system. It also generates reports to
monitor and review auditor resource allocation and scheduling, draft and formal audit reports, and reports to track and trend
findings and corrective actions to enable continuous improvement.
TrackWise Auditing Solutions Sparta Systems www.spartasystems.com
The system allows an administrator to define user roles, as well as specific permissions and assignments directly from pre-existing
enterprise applications. The creation of user accounts for supplier and customer access portals and web forms can be automated.
TrackWise can also interact with other enterprise software systems through a web services interface, thus enabling constant
communication with enterprise resource planning, customer relationship management, laboratory information management systems,
and manufacturing execution systems software.
Mixer performs under full-scale conditions
Silverson's Verso In-Line laboratory mixer is equipped with a digital tachometer, integral programmable timer, and simultaneous
amp reading, thus allowing the user to monitor power draw and mixer speed over time throughout the mixing process. It operates
at variable speeds as high as 8000 rpm. The unit incorporates single or multistage interchangeable workheads and stator screens.
Verso In-Line Laboratory Mixer Silverson Machines www.silverson.com
The mixer has a 1-hp drive unit and a self-pumping flow rate of as much as 6.5 gal/min. Its instrumentation is augmented by
the Silverson DataLogger program, which allows the user to plot information in a graph and archive readings or integrate them
into databases. The Verso is a sanitary mixer designed for clean-in-place capabilities. The unit incorporates the design features
of larger mixers in Silverson's UHS range.
Software manages information in a centralized enterprise system
Honeywell's vendor-neutral process-control suite allows plant operators to centrally monitor and control process-control systems.
It is designed to avoid the information silos that can be created by Advanced Process Control (APC) systems.
Process-control suite Honeywell Process Solutions http://hpsweb.honeywell.com
The suite contains Honeywell's Loop Scout software, which gives control engineers the ability to identify and correct poorly
performing control loops. In addition, the Control Performance Monitor detects, identifies, diagnoses, and remedies regulatory
and APC asset issues throughout the plant.
The Honeywell Process Solutions suite can work with various APC technologies and processing facilities, thus contributing
to consistent performance benchmarking across the enterprise and ensuring that proper corrective action is taken if necessary.